I-Supernus Pharmaceuticals, Inc. imemezele ukuthi i-US Food and Drug Administration (FDA) igunyaze inkomba enwetshiwe ye-Qelbree (i-viloxazine ekhishwa amaphilisi okwesikhathi eside) yokwelashwa kwe-attention deficit hyperactivity disorder (ADHD) ezigulini ezikhulile ezineminyaka engu-18 nangaphezulu. I-FDA manje isigunyaze i-Qelbree yokwelashwa kwe-ADHD ezinganeni (kusukela eminyakeni eyi-6), intsha kanye nabantu abadala.
Cishe izingane eziyizigidi ezingu-16, intsha, kanye nabantu abadala bane-ADHD e-US Nakuba izingane eziningi ezine-ADHD zikhula ngaphezu kwayo, kufika ku-90% walabo abatholakala bene-ADHD ebuntwaneni bayaqhubeka nokuba ne-ADHD njengabantu abadala.
"Kuze kube namuhla, izinketho ezingakhuthazi ze-ADHD kubantu abadala zilinganiselwe kakhulu," kusho uGreg Mattingly, MD, uzakwethu owasungula i-St. Charles Psychiatric Associates e-St. Louis, Mo. "Le mvume iyizindaba ezinhle futhi inikeza inketho entsha yenoveli izigidi zabantu abadala baseMelika abazama ukuthola ukwelashwa okufanele ukuze balawule izimpawu zabo ze-ADHD.”
I-Qelbree iyinoveli engakhuthazi ethathwa kanye ngosuku ukuze kuvezwe usuku olugcwele. Ukusebenza kahle kanye nokuthuthukiswa kwezimpawu kwabonwa ekuqaleni kokwelashwa. Inephrofayili efakazelwe yokuphepha nokubekezeleleka, abukho ubufakazi bamandla okuhlukumeza ezifundweni zomtholampilo. Ukugunyazwa kusekelwe emiphumeleni emihle evela ocwaningweni olungahleliwe, olungaboni kabili, olulawulwa yi-placebo lweSigaba III se-Qelbree kubantu abadala abane-ADHD futhi lumelela ukugunyazwa kokuqala kokwelashwa kwenoveli okungakhuthazi kubantu abadala eminyakeni engu-20.
"Njengomholi emkhakheni we-CNS, sizibophezele ngokugcwele ekuqondeni kangcono indlela yokwelapha izifo eziyinkimbinkimbi ezifana ne-ADHD," kusho uJack Khattar, uMongameli kanye ne-CEO ye-Supernus Pharmaceuticals. “Ukugunyazwa kwanamuhla kubonisa intuthuko enkulu ekwelapheni i-ADHD futhi kuyingqopha-mlando ebalulekile nje onyakeni owodwa ngemva kokugunyazwa kuka-Qelbree ukwelapha iziguli zezingane. Siyaziqhenya ngokuletha inketho entsha yenoveli engakhuthazi kubantu abadala emakethe ngemva kwamashumi amabili eminyaka.”
Ngedosi eguquguqukayo yansuku zonke phakathi kuka-200mg kuya ku-600mg, uhlolo lweSigaba III luhlangabezane nesiphetho esiyinhloko esibonisa ukuncipha koshintsho olusuka kusisekelo se-Adult ADHD Investigator Symptom Rating Scale (AISRS) ekupheleni kocwaningo belulukhulu ngokwezibalo kubantu abadala. ukwelashwa nge-Qelbree ngokumelene ne-placebo (p=0.0040). Ukuthuthuka okuphawulekayo kuzikolo eziphansi ze-AISRS zokunganaki kanye nezimpawu zokusebenzisa ngokweqile/ukusukumela phezulu nazo zabonwa ocwaningweni. Ngaphezu kwalokho, lolu cwaningo luhlangabezane nesiphetho esibalulekile sokuphumelela kwesibili ngokubaluleka kwezibalo (p = 0.0023) ekushintsheni kusukela kusisekelo se-Clinical Global Impression - Severity of Illness (CGI-S) Scale ngeviki 6. Umthamo osebenzayo wawubekezelelwa kahle. Sicela ubheke Ulwazi Olungeziwe Olubalulekile Lokuphepha olufakwe ngezansi.
I-1 Qelbree yafundwa ezivivinyweni ze-4 zomtholampilo. Ocwaningweni olulodwa lwezingane ezineminyaka engu-6 kuye kweyi-11 ubudala, ukuncipha kwezimpawu ze-ADHD kwakubalulekile ngokwezibalo kumithamo engu-100 mg kanye ne-200 mg, kusukela ngesonto loku-1. Ocwaningweni lwentsha eneminyaka engu-12 kuya kweyi-17 ubudala, ukuncipha kwezimpawu ze-ADHD kwakungokwezibalo. okubalulekile ku-400 mg, kuqala ngeviki lesi-2. Ocwaningweni lwedosi eguquguqukayo lwabantu abadala abaneminyaka engu-18 kuya kwengama-65 ubudala, ukuncipha kwezimpawu ze-ADHD kwakubaluleke ngokwezibalo ezigulini ze-Qelbree, kusukela ngeviki lesi-2.
ULWAZI OLUBALULEKILE LOKUPHEPHA
U-Qelbree angase akhulise imicabango nezenzo zokuzibulala, ezinganeni nakubantu abadala abane-ADHD, ikakhulukazi phakathi nezinyanga ezimbalwa zokuqala zokwelashwa noma lapho umthamo ushintshwa. Tshela udokotela wakho uma une (noma uma kunomlando womndeni) wemicabango yokuzibulala noma izenzo ngaphambi kokuqala i-Qelbree. Gada imizwa yakho, indlela oziphatha ngayo, imicabango kanye nemizwa yakho ngesikhathi sokwelashwa ngo-Qelbree. Bika noma yiziphi izinguquko ezintsha noma ezizumayo kulezi zimpawu ngokushesha. I-Qelbree akufanele iphuzwe iziguli ezithatha nemithi ethile yokulwa nokucindezeleka, ikakhulukazi leyo ebizwa ngokuthi i-monoamine oxidase inhibitor noma i-MAOI, noma imithi ethile yesifuba somoya.
LOKHO ONGAKUTHATHE KULESI SIHLOKO:
- At a daily flexible-dose between 200mg to 600mg, the Phase III trial met the primary endpoint showing the reduction in the change from baseline of the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score at end of study was statistically significantly greater in adults treated with Qelbree versus placebo (p=0.
- The approval is based on positive results from a randomized, double blind, placebo-controlled Phase III study of Qelbree in adults with ADHD and represents the first approval of a novel nonstimulant treatment for adults in 20 years.
- “Today’s approval marks a major advancement in the treatment of ADHD and is an important milestone just one year after the approval of Qelbree to treat pediatric patients.
